Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT02876159
Status:
COMPLETED
Last Update Posted:
2018-12-12
First Post:
2016-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Immunologic Basis for an Attenuated Immune Response to the Influenza Vaccine After Repeated Annual Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mmulli2@emory.edu', 'phone': '404-712-1370', 'title': 'Dr. Mark J. Mulligan, M.D., F.I.D.S.A', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The numbers of subjects in this pilot study are small. A larger study will be required for confirmation of the outcome measures'}}, 'adverseEventsModule': {'timeFrame': "Adverse Events (AE's) data was collected from the participant signing the informed consent to Day 29 post vaccination.", 'eventGroups': [{'id': 'EG000', 'title': 'Vaccination Naïve', 'description': 'Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.\n\n2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vaccination Experienced', 'description': 'Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.\n\n2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Geometric Mean Serum Hemagglutination Inhibition (HAI) Antibody Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccination Naïve', 'description': 'Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.\n\n2016-2017 Influenza Vaccine: Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1), A/Influenza A virus subtype (H3N2), B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.'}, {'id': 'OG001', 'title': 'Vaccination Experienced', 'description': 'Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.\n\n2016-2017 Influenza Vaccine: Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1)/ Influenza A virus subtype H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '23', 'spread': '19.9', 'groupId': 'OG000'}, {'value': '56.5', 'spread': '95.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '188', 'spread': '191.4', 'groupId': 'OG000'}, {'value': '108', 'spread': '89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Day 29', 'description': 'Geometric mean serum HAI antibody titers serum HAI titer will be collected via blood draw. Titer for serum HAI antibodies will be calculated using the geometric mean. Change is defined as the difference in means from Day 1 to Day 29.', 'unitOfMeasure': 'HAI antibody Titers', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Mean Level of Circulating Follicular Helper T (TFH) Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccination Naïve', 'description': 'Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.\n\n2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.'}, {'id': 'OG001', 'title': 'Vaccination Experienced', 'description': 'Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.\n\n2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '13.8', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '2.96', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '4.1', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '4.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 15 Days', 'description': 'TFH cells will be collected via blood draw. Change is defined as the difference in the mean levels of cells from baseline, day 8, and day 15.', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Mean Levels of Plasmablasts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccination Naïve', 'description': 'Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.\n\n2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.'}, {'id': 'OG001', 'title': 'Vaccination Experienced', 'description': 'Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.\n\n2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '2.5', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '6.7', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'categories': [{'measurements': [{'value': '2.3', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 29 Days', 'description': 'Plasmablasts will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Mean Levels of Memory B Cells From Baseline (Day 1) to Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccination Naïve', 'description': 'Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.\n\n2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.'}, {'id': 'OG001', 'title': 'Vaccination Experienced', 'description': 'Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.\n\n2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '0.46', 'spread': '0.72', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '0.71', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '0.48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) and Day 29', 'description': 'Memory B cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'only 9 participant samples were analyzed as 1 sample could not be analyzed'}, {'type': 'SECONDARY', 'title': 'Change in Mean Levels of Antigen-specific IL-2 Producing CD4+ T Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccination Naive', 'description': 'Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.\n\n2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.'}, {'id': 'OG001', 'title': 'Vaccination Experienced', 'description': 'Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.\n\n2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '0.018', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.018', 'spread': '0.017', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'categories': [{'measurements': [{'value': '0.013', 'spread': '0.097', 'groupId': 'OG000'}, {'value': '0.038', 'spread': '0.024', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 29 Days', 'description': 'Antigen-specific Interleukin 2 (IL-2) producing cluster of differentiation 4 (CD4)+ T cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Mean Levels of Antigen-specific Cluster of Differentiation 8 (CD8) + T Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccination Naive', 'description': 'Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.\n\n2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.'}, {'id': 'OG001', 'title': 'Vaccination Experienced', 'description': 'Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.\n\n2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.'}], 'timeFrame': 'Up to 29 Days', 'description': 'CD8+T cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.', 'reportingStatus': 'POSTED', 'populationDescription': 'CD8+T cell assays were not collected since the split virus influenza vaccine was not likely to induce any detectable CD8+ T cell responses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vaccination Naïve', 'description': 'Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.\n\n2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.'}, {'id': 'FG001', 'title': 'Vaccination Experienced', 'description': 'Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.\n\n2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants for this study were enrolled from 07/01/2016 to 09/30/2016. Clinical study was conducted at Hope Clinic of Emory University.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Vaccination Naïve', 'description': 'Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.\n\n2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.'}, {'id': 'BG001', 'title': 'Vaccination Experienced', 'description': 'Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.\n\n2016-2017 Influenza Vaccine: Quadrivalent influenza A/H1N1, A/H3N2, B virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23.4', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '24.6', 'spread': '2.2', 'groupId': 'BG001'}, {'value': '24.0', 'spread': '2.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '25.7', 'spread': '8', 'groupId': 'BG000'}, {'value': '22.8', 'spread': '2.77', 'groupId': 'BG001'}, {'value': '24.3', 'spread': '5.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-11', 'studyFirstSubmitDate': '2016-08-04', 'resultsFirstSubmitDate': '2018-11-05', 'studyFirstSubmitQcDate': '2016-08-18', 'lastUpdatePostDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-11', 'studyFirstPostDateStruct': {'date': '2016-08-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Geometric Mean Serum Hemagglutination Inhibition (HAI) Antibody Titer', 'timeFrame': 'Baseline (Day 1), Day 29', 'description': 'Geometric mean serum HAI antibody titers serum HAI titer will be collected via blood draw. Titer for serum HAI antibodies will be calculated using the geometric mean. Change is defined as the difference in means from Day 1 to Day 29.'}, {'measure': 'Change in Mean Level of Circulating Follicular Helper T (TFH) Cells', 'timeFrame': 'Up to 15 Days', 'description': 'TFH cells will be collected via blood draw. Change is defined as the difference in the mean levels of cells from baseline, day 8, and day 15.'}], 'secondaryOutcomes': [{'measure': 'Change in Mean Levels of Plasmablasts', 'timeFrame': 'Up to 29 Days', 'description': 'Plasmablasts will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.'}, {'measure': 'Change in Mean Levels of Memory B Cells From Baseline (Day 1) to Day 29', 'timeFrame': 'Baseline (Day 1) and Day 29', 'description': 'Memory B cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.'}, {'measure': 'Change in Mean Levels of Antigen-specific IL-2 Producing CD4+ T Cells', 'timeFrame': 'Up to 29 Days', 'description': 'Antigen-specific Interleukin 2 (IL-2) producing cluster of differentiation 4 (CD4)+ T cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.'}, {'measure': 'Change in Mean Levels of Antigen-specific Cluster of Differentiation 8 (CD8) + T Cells', 'timeFrame': 'Up to 29 Days', 'description': 'CD8+T cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vaccination'], 'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': 'This is a prospective pilot study designed to suggest differences in the immunologic response to the seasonal influenza vaccine in people with regular vaccination history compared to those vaccinated less regularly. Participants will receive one dose of the Food and Drug Administration (FDA) approved 2016-2017 seasonal influenza vaccine. Immune system data will be collected at standard time points. The duration of the study for each participant will be approximately 1 month.', 'detailedDescription': 'This is a prospective pilot study in 20 males and non-pregnant females, 20 to 30 years old, inclusive, who are in good health and meet all eligibility criteria. The study is designed to evaluate differences in the immunologic response to the seasonal influenza vaccine in people with regular vaccination history compared to those vaccinated less regularly.\n\nParticipants will be sorted to either Arm A (Naïve) or Arm B (Experienced) based on their vaccination history. Those vaccinated no more than 2 out of the past 5 years will be in Arm A. Those vaccinated 3 or more out of the past 5 years will be in Arm B. Participants will receive one dose of the Food and Drug Administration (FDA) approved 2016-2017 seasonal influenza vaccine. The duration of the study for each participant will be approximately 1 month. Subjects will return for clinic visits on Days 3, 8, 15, and 29 during the month follow-up period following vaccination.\n\nThe study has two primary objectives; to evaluate the antibody response to the influenza vaccine in people who are vaccinated regularly and those vaccinated less regularly; the second is to evaluate circulating follicular helper T cells (TFH) in people who are vaccinated regularly and those vaccinated less regularly.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Capable of informed consent and provision of written informed consent before any study procedures.\n* Capable of attending all study visits according to the study schedule.\n* Are in good health, as determined by medical history and targeted physical exam related to this history.\n* Oral temperature is less than 38 degrees Celsius.\n* Resting pulse rate is between 50 and 115 beats per minute.\n* Female subjects of childbearing age must have a negative urine pregnancy test within 24 hours before study vaccination.\n* Have received the influenza vaccine at least 3 of the past 5 years or have received the influenza vaccine in 2 or less of the past 5 years.\n\nExclusion Criteria:\n\n* Have an acute illness within 72 hours before vaccination.\n* Have any condition that, in the opinion of the principal investigator, would place the subject at an unacceptable risk of injury or confound the interpretation of the study results.\n* Have any acute or chronic medical condition that, in the opinion of the principal investigator, would make vaccination unsafe or interfere with the evaluation of immune response to study vaccination.\n* Have a suppressed immune system as a result of illness, immunosuppressive medication, chemotherapy, or radiation therapy within 3 years prior to study vaccination.\n* Have known HIV, hepatitis B, or hepatitis C infection.\n* Have a known history of autoimmune disease.\n* Have taken oral or parenteral corticosteroids of any dose within 30 days before study vaccination.\n* Have taken high-dose inhaled corticosteroids within 30 days before study vaccination.\n* Have received any licensed live vaccine within 30 days or any licensed inactivated vaccine within 14 days prior to study vaccination.\n* Have planned vaccination with any vaccine during the 29-day duration of subject study participation.\n* Have received immunoglobulin or other blood products, with the exception of Rho D immunoglobulin, within 90 days prior to study vaccination.\n* Have donated blood or blood products within 30 days before study vaccination, plan to donate blood at any time during the 29-day duration of subject study participation, or plan to donate blood within 30 days after the last blood draw.\n* Have known hypersensitivity or allergy to eggs, egg protein, chicken protein, or other compounds of the study vaccine.\n* Have a history of severe reactions following vaccination with influenza virus vaccines'}, 'identificationModule': {'nctId': 'NCT02876159', 'acronym': 'FLU1', 'briefTitle': 'The Immunologic Basis for an Attenuated Immune Response to the Influenza Vaccine After Repeated Annual Vaccination', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'The Immunologic Basis for an Attenuated Immune Response to the Influenza Vaccine After Repeated Annual Vaccination', 'orgStudyIdInfo': {'id': 'IRB00090196'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vaccination Naïve', 'description': 'Participants who have received an influenza vaccine in 2 or less of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.', 'interventionNames': ['Biological: 2016-2017 Influenza Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Vaccination Experienced', 'description': 'Participants who have received an influenza vaccine at least 3 of the past 5 years will receive the FDA-approved 2016-2017 influenza vaccine.', 'interventionNames': ['Biological: 2016-2017 Influenza Vaccine']}], 'interventions': [{'name': '2016-2017 Influenza Vaccine', 'type': 'BIOLOGICAL', 'description': 'Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1), A/Influenza A virus subtype (A/H3N2) H3N2,and B virus vaccine for Intramuscular (IM) use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.', 'armGroupLabels': ['Vaccination Experienced', 'Vaccination Naïve']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'The Hope Clinic of the Emory Vaccine Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Mark Mulligan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mark Mulligan', 'investigatorAffiliation': 'Emory University'}}}}